Part 5Amendment to Part 4 (Good Clinical Practice and the Conduct of Clinical Trials)

Amendment to regulation 28

regulation 17 + 17.—(1) Regulation 28 (good clinical practice and protection of clinical trial subjects) is amended as follows.

(2) In the heading, for “subjects” substitute “participants”.

(3) After paragraph (1) insert—

“(1A) The conditions and principles of good clinical practice include those in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, as amended from time to time(1).

(1B) For the avoidance of doubt—

(a)the functions of the sponsor include functions in relation to—

(i)the development and maintenance of trial specific computerised systems, and

(ii)the selection and oversight of a laboratory in relation to the analysis or evaluation of human samples collected as part of the clinical trial; and

(b)conducting a trial includes the analysis or evaluation of human samples collected as part of the clinical trial.”.

(4) In paragraph (3), for “subjects” substitute “participants”.

(5) In paragraph (4), for “subject” substitute “participant”.

(6) In paragraph (5)—

regulation 17 6 a + (a)for “site”, in both places where it occurs, substitute “location”;

regulation 17 6 b + (b)for “sites”, in both places where it occurs, substitute “locations”.

Amendment to regulation 29

regulation 18 + 18.—(1) Regulation 29 (conduct of trial in accordance with clinical trial authorisation etc.) is amended as follows.

(2) In paragraphs (a) and (b)—

regulation 18 2 a + (a)for “amended” substitute “modified”;

regulation 18 2 b + (b)for “regulations 22 to 25” substitute “regulations 20 to 22C”.

(3) In paragraph (c)(2)—

regulation 18 3 a + (a)omit “by the licensing authority”;

regulation 18 3 b + (b)for “regulation 18(2) or (6), 19(8), 20(5), 24(5)” substitute “regulation 18(3), 18B(3), 22A(4), 22C(3)”.

Amendment to regulation 29A

regulation 19 + 19.—(1) Regulation 29A (notification of serious breaches)(3) is amended as follows.

(2) In paragraph (1)(b)—

regulation 19 2 a + (a)for “amended” substitute “modified”;

regulation 19 2 b + (b)for “regulations 22 to 25” substitute “regulations 20 to 22C”.

(3) In paragraph (2)(a), for “subjects” substitute “participants”.

Amendment to regulation 30

regulation 20 + 20.—(1) Regulation 30 (urgent safety measures) is amended as follows.

(2) In paragraph (1), for “subjects” substitute “participants”.

(3) In paragraph (2)(b)(4), for “3 days” substitute “7 days”.

Amendment to regulation 31

regulation 21 + 21.—(1) Regulation 31 (suspension or termination of clinical trial) is amended as follows.

(2) In paragraph (1)—

regulation 21 2 a + (a)after “clinical trial” insert “or part of a clinical trial”;

regulation 21 2 b + (b)in sub-paragraph (a)(ii)(5)—

regulation 21 2 b i + (i)omit “by the licensing authority”;

regulation 21 2 b ii + (ii)for “regulation 18(2) or (6), 19(8), 20(5), 24(5)” substitute “regulation 18(3), 18B(3), 22A(4), 22C(3)”;

regulation 21 2 c + (c)in the words after sub-paragraph (a)(ii), for “site); or” substitute “location);”;

regulation 21 2 d + (d)in sub-paragraph (b), for “site,” substitute “location; or”;

regulation 21 2 e + (e)after sub-paragraph (b), insert—

“(c)the trial has lapsed in accordance with regulation 26 and the sponsor has not notified the licensing authority that the trial has ended,”.

(3) In paragraph (2), for “trial site”, in each place where it occurs, substitute “trial location”.

(4) In paragraph (3)—

regulation 21 4 a + (a)in sub-paragraph (a), for “sites” substitute “locations”;

regulation 21 4 b + (b)in sub-paragraph (b), after “the trial” insert “in whole or in part, and, if it applies to part of the trial, to which part it applies”;

regulation 21 4 c + (c)in sub-paragraph (c)(ii), for “site” substitute “location”.

(5) In paragraph (5)—

regulation 21 5 a + (a)for “site”, in both places where it occurs, substitute “location”;

regulation 21 5 b + (b)in sub-paragraph (a), after “terminating the trial” insert “(in whole or in part)”.

(6) In paragraph (6), for “subjects” substitute “participants”.

Amendment to regulation 31A

regulation 22 + 22.—(1) Regulation 31A (trial master file and archiving) is amended as follows.

(2) In paragraph (7)—

regulation 22 2 a + (a)at the beginning, insert “Subject to paragraph (7A),”;

regulation 22 2 b + (b)after “master file” insert “(including documents contained in electronic form)”;

regulation 22 2 c + (c)for “5 years” substitute “the period of 25 years beginning with the day”.

(3) After paragraph (7) insert—

“(7A) If, at the date of the expiry of the 25 years referred to in paragraph (7), the data generated by the trial is being used to support an application for a UK marketing authorization, the sponsor shall ensure the documents referred to in paragraph (7) are retained for at least the period of 2 years beginning with the day after the grant of that UK marketing authorization.”.

(4) In paragraph (8)—

regulation 22 4 a + (a)for “subjects” substitute “participants”;

regulation 22 4 b + (b)for “5 years after conclusion of the trial” substitute “the period of 25 years beginning with the day after conclusion of the trial, or such period as is required by any other enactment, if longer”.